Published online Nov 25, 2021. doi: 10.5527/wjn.v10.i6.109
Peer-review started: May 9, 2021
First decision: June 6, 2021
Revised: August 19, 2021
Accepted: September 15, 2021
Article in press: September 15, 2021
Published online: November 25, 2021
Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach.
To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD).
This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36.
All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators’ assessment. At week 12, the QoL scores in all domains were significantly increased from baseline.
Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.
Core Tip: This was an open-label, single-arm, prospective, multicenter study of Hema-Plus®, a recombinant human erythropoietin (rHuEPO) for management of anemia in 30 Thai chronic kidney disease patients who started peritoneal dialysis with hemoglobin (Hb) lower than 9.5 g/dL and who had not previously received epoetin. The results showed that the rHuEPO could significantly increase Hb from baseline throughout the 12-wk treatment duration with acceptable safety profile. The quality of life (QoL) scores at week 12 assessed using KDQOL-36 were significantly increased from baseline in all domains.